Ecological Momentary Assessment in Patients With Restless Legs Syndrome

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Jan 13, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how symptoms of Restless Legs Syndrome (RLS) can change throughout daily life. RLS is a condition that causes an uncomfortable urge to move the legs, especially when resting. While there are treatments available, many people still experience ups and downs in their symptoms. The trial aims to use mobile technology to gather real-time information about these symptom changes and to find out what daily activities or behaviors might trigger or worsen them.

To participate in the study, you need to be between 18 and 70 years old and have a confirmed diagnosis of idiopathic RLS. Participants will be asked to provide consent and will use mobile devices to report their symptoms regularly. It's important to know that individuals with certain psychiatric conditions, chronic pain issues, or other significant health problems may not be eligible to join the trial. This study is currently looking for volunteers, and it's a great opportunity to contribute to research that could help improve the understanding and treatment of RLS.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient over 18 years old and less than 70
• • Any patient with a diagnosis of idiopathic RLS based on medical history and the presence of the 5 RLS diagnostic criteria
• • Normal clinical examination
• • Person affiliated or benefiting from a social security scheme
• • Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and prior to any review required by the research).
• Exclusion Criteria:
• • Any significant psychiatric illness (schizophrenia, bipolar disorder, severe depression, dementia, obsessive compulsive disorder, attention-deficit/hyperactivity disorder ...) or mood disorder
• • History or presence of chronic pain other than that associated with RLS, history of epilepsy or serious head injury, history of peripheral neuropathy, diabetes
• • Clinically significant sleep apnea, narcolepsy, or any secondary causes of RLS (e.g. chronic renal failure/hemodialysis, pregnancy)
• • Other active clinically significant illness, including unstable cardiovascular, or neoplasic pathology which could interfere with the study conduct or interfere with study assessments or compromise the study participation
• • Pregnant or breastfeeding woman
• • Persons referred to in articles L.1121-5 to L.1121-8 (persons deprived of liberty by judicial or administrative decision, minors, adults subject to a legal protection measure or unable to express their consent).